Vaxess – Michael Schrader on the digital future of pharmaceuticals.

“Big Pharma’ is a bastion of old-school processes. Relying on the methodical and proven techniques that have driven medical advancements over the last half-century, there has been widespread resistance to digital transformation.

Michael Schrader is working to change that. He is the Co-Founder and CEO of Vaxess Technologies, a life science company developing a silk biopolymer platform capable of bringing stabilized biologic compounds out of the clinic and into patients homes.

In addition to pursuing innovative technologies that will bring healthcare administration up to the home-flexible standards of a generation raised on Amazon, Vaxess is embracing a number of digital solutions in their labs that are poised to change how large pharma companies approach R&D.

Michael provides insights into the future of drug development and the necessary changes required in the industry to create a future capable of delivering better healthcare solutions at lower costs through taking advantage of digital transformation.”

Insightive.tv: How is Vaxess’ approach different from the traditional methods used in pharma?

Michael: From the start, we have tried to use lean development practices and get customer feedback early on in the process — something that looks a lot more like a digital development strategy you might see for a website or app.

My experience working at Google taught me the importance of empowering employees. One thing that we screen for in interviews is “tolerance for uncertainty” — how comfortable are people being thrown into new environments. I think that is one of the most important requirements for thriving in a digitally transformed world. We have quite a few people in positions that are traditionally given only to more senior PhDs who got there because of their ability to spot new opportunities and deliver tremendous results going after them.

We place a premium on adopting new technology within our labs. For example, even though a host of digital lab notebook platforms have come online over the last 5-8 years, adoption amongst big pharma has been slow. A key recruiting tool for us, believe it or not, is being able to offer the ability to operate digitally within the lab.

Technology enables cross-team communication, but also provides the ability to comb through old data sets and summarise experiments. We see growing opportunities to submit data from a wide range of studies to digital assessment by AI and machine learning protocols that can pick up correlations missed during manual assessment. Some of the largest players in the industry have teams that are completely unaware of other experiments going on even within their company. In large part, that is because there hasn’t been widespread digital adoption. Bringing this technology into the larger firms could dramatically change the speed and nature of healthcare development.

Ultimately, we are working to move healthcare out of the clinic and into patients’ lives. We are doing that through working more closely with patients than ever before and adopting the latest digital technology at all stages of our process.

Insightive.tv: What is the potential you see for digital development — where could we be if we make the right choices now?

Michael: The big thing that digital can bring to pharma is speeding up the development process. A huge aspect of that is improving access to the reams of data generated by different scientists working on different experiments. That comes down to digitising the lab.

Looking to the future, I am most excited about the potential for quantum computing systems to more accurately predict how compounds will interact with the human body. The dream situation is that in 20-25 years we could use computer models to move away from the traditional clinical trial system that has been necessary, in part, due to our limited understanding of the complex systems of the human body and how these compounds will behave.

I think we are looking at the eventual possibility of cutting the drug development process from 10-20 years down to 3-5.We will also increase our ability, using purely digital tools, to screen out bad ideas much earlier in the process — all of which will dramatically decrease development costs and improve patient outcomes.

As one example, GSK has an interesting experimental technology that combines digital innovation with a novel mRNA vaccine platform. This combination allows them to identify a newly emerging virus on the other side of the world and go from a digital genetic sequence to a functioning vaccine in 8 days. That sounds like science fiction — but has already been demonstrated.

Insightive.tv: What is stopping digital adoption across the industry — how do we help these larger breakthroughs occur?

Michael: The problem is threefold. One is simply a risk-averse mentality. The second is a lack of competition, particularly in the world of vaccines. As an example, Merck is the only MMR vaccine provider in the US so there is little incentive for them to really innovate in this field.

The big hurdle, however, is timeframes. We are working on products that, best case scenario, are 5 years from market — more often that is 10-15 years.

Any kind of transformational platform is going to have to go through the proving grounds of the old-fashioned approach — full phase 1-3 human clinical trials. The challenge, whether you are a large pharma company or venture capital firm, is looking at this and being able to justify the huge upfront investment for something that won’t come out for nearly two decades.

Ultimately, I think that this is something that will only be kick-started by government and grant assistance. Organisations like the NIH, NSF, or perhaps the Gates Foundation, have the ability to look that far down the road and subsidise the first 5-10 years of development to get the industry to the point that private capital will be willing to step in and finish the job.

We are six years old. That isn’t particularly new for a startup, but it is an infant in terms of pharma. Our journey started by looking at Amazon and the impact they had on retail. There is a generation of consumers coming up that basically expects to be able to do anything they want from the comfort of their own home. Some of these opportunities are already starting to emerge — you see sites like ‘doctors on demand’ that allow you to get healthcare services from home.

Imagine that you go to the doctor with an ear infection, they swab your ear and can tell you not only what you have, but the particular strain of bacteria. Then, they could synthesise, on the spot, a tailor-made drug with the exact dosage necessary for you and your condition through some kind of 3D printing.

One step further would be eliminating the need to go to the doctor at all. Bringing technology into the home that could analyse a swab, send that information to the cloud and enable a developer to synthesise the necessary drugs and mail them to your house. I think there is a distinct possibility of home diagnostic tests becoming reality within our lifetimes.

The Holy Grail, however, of digital transformation in pharma, is being able to eliminate clinical trials through the use of hyper-accurate computer models. It is just going to require determination and drive by the right players in the industry. Personally, I am very excited. It is what we are working to help make a reality.